A tracheostomy is a surgical procedure in which an opening is formed through the anterior surface of the neck into the trachea. The opening is referred to as a tracheostoma. A tracheostomy tube can be provided to extend between the tracheostoma and the trachea. A tracheostomy is performed for example when there is a malfunction, such as a result from injury or disorder, in respect of the nervous system or the respiratory passages, which malfunction results in an incapacity to obtain enough air. An inferior lung capacity or need of respiratory treatment may also result in a tracheostomy.
A laryngectomy is a surgical procedure, used for example to treat a carcinoma, which involves removal of the larynx or voice box and the creation of a tracheostoma. A consequence of the procedure is that the trachea is no longer connected to the pharynx but is diverted to the tracheostoma. After this procedure, normal nasal function is not possible. In a subject whose breathing functions normally, the nose and the mucous membrane lining of the nasal cavity perform important functions in conditioning inhaled air. The convoluted passages and rich blood supply serve to increase both the temperature and humidity of the inhaled air to minimise the differential in these parameters with those of the surface of the lungs. Normally some heat and moisture is also captured from exhaled air prior to its release to the atmosphere. The mucous lining of the nasal passages also serves to remove particulate matter, such as fine dust particles, pollutants and microorganisms, from the inhaled air, and the action of cilia transports mucous and any particles away from the lungs.
When a patient has received a laryngectomy, in effect all inhaled air enters the lungs via the tracheostoma, and the nose is effectively not involved in the inhalation process. Exhaled air may pass through the tracheostoma or, if a voice prosthesis has been fitted, the stoma can be occluded so that the exhaled air is diverted through the voice prosthesis into the pharynx and the mouth, enabling the patient to speak. It is desirable that the flow of the exhaled air be controlled by means of a tracheostoma valve. In these situations, the valve can be arranged to remain open during breathing but, with a small additional increase in exhaled air flow, can be closed to divert the airflow.
In this respect tracheostoma devices, such as filter devices, HME, breathing protectors, and speech valves, have been developed to enable moisturizing of inhaled air, removal of small particles and bacteriological substances in said inhaled air, and providing the patient with the ability to speech by closing the air passage through the tracheostoma by manual operation.
These tracheostoma devices are held in place by a tracheostoma device holder, arranged above the tracheostoma of the patient. The tracheostoma device holder is attached to the skin of the patient by a plaster, having an adhesive surface on the side of the plaster intended to be directed towards the patient in use. Either, the tracheostoma device holder is welded to the plaster, or the tracheostoma device holder is on an adhesive surface on the side of the plaster intended to be directed outwards from the patient in use.
U.S. Pat. No. 7,025,784 discloses a system wherein a circular tape, adhesive on both sides, is used to adhere a tracheostoma device holder, above the tracheostoma of the patient. However, this tape is accompanied by the drawbacks that the adhesive area towards the patient is limited by the area of the tracheostoma device holder. Otherwise, the tape will adhere to clothings etc. on the side facing outwardly from the patient. The user or applier will have to hold tubular part, while the skin adhesive part extends radially. Thus, it is difficult to adhere this system in pit in between the sternocleidomastoid muscles, at patients with sunken stomas, i.e. stomas that somewhat sunken into the throat of the patient, since the adhesive surface of the system inevitably will adhere to the walls of the pit before reaching the bottom of the pit with the central portion of the system. Sunken stomas are very frequent in the group of patients not having the two vertical sternocleidomastoid muscles on the neck cut during laryngectomy. Thus, this system is only suitable for mildly or non-sunken stomas. Furthermore, due to the stiffness needed to withstand flipping over at high speech pressure, the circular shape of the rigid portion prevents the system from allowing good accessibility with sunken stomas. Nevertheless, it is very common that these kind of systems still flip over, since the bad connection between adhesives and skin and the axial displacement of the speech pressure resulting in loosening of the system and need of unduly high speech pressure. Also, due to the types of tracheostoma device holders applied to these kinds of tapes are exclusively for multi usage. Thus, the tracheostoma device holder of this kind has to be cleaned with strong solvents in between usage. Also, in this way, guidance of the system during application to the patient is almost entirely absent, since the flexibility of the tape is too high. U.S. Pat. No. 4,325,366 and WO 2004/000401 disclose similar systems with planar and circular tape, and circular and convex tape, respectively.
In this respect U.S. Pat. No. 5,738,095 and U.S. Pat. No. 5,042,468 disclose systems wherein the tracheostoma device holder is welded to a plaster, to form planar and circular tracheostoma device holder/plaster systems. However, these systems are not suitable for patients with sunken stomas and are difficult to apply due to uniform plasticity of the systems. Thus, the tubular holding portion of the systems will be deformed during application, leading to a perhaps unsatisfactory holding action of the tracheostoma device.
Also, all of the tracheostoma device holder systems according to the prior art expose the entire adhesive surface on the side intended to face the patient, before application, whereby application is difficult due to high demands of exact and correct initial positioning of the tracheostoma device holder system is required. Otherwise, the tracheostoma device holder system has to be disengaged and repositioned.
Furthermore, in many hospitals the surgical steps during laryngectomy are adapted for creating stomas of substantially planar natures, to comply with the tracheostoma device holder system presently on the market. This adaptation includes the cutting of the two vertical sternocleidomastoid muscles on the neck.
Hence, an improved holder system for a tracheostoma device holder system would be advantageous, and in particular a tracheostoma device holder system allowing for convenient application of the system with improved positioning ability, improved resistance to deformation of the tracheostoma device holder, allowance for non-adhesive parts on the side facing outwardly from the patient, improved compliance with sunken stomas and even deeply sunken stomas, and improved compliance with manifoldness of stoma configurations.